"Primum Non Nocere" ["First Do No Harm"][PDF]
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Lindblad Informed Consent "Primum non nocere" ("First do no harm") Medical ethics standard attributed to Hippocrates. This Oath became obligatory for physicians prior to practicing medicine in the 4th century AD Everyone agrees there is positive value in ensuring, providing and obtaining Informed Consent when contemplating research with human subjects. For most researchers informed consent is now accepted as an ethical requirement of the research process. (5) Given the atmosphere surrounding medical research in the United States today, no one is willing to publicly renounce the concept. The fireworks begin with the discussions about how to define Informed Consent, who can give and who can get Informed Consent, what information needs to be disclosed in Informed Consent Documents, how much is to much, what constitutes coercion. The major problem is that there is no agreed upon, standardized method to determine adequate informed consent. 56 57 The differences in opinion emerge when we approach Informed consent as a process, not a document. At the center of this debate is the volunteer/subject/ participant or patient. Without this “researchee” there exists no way for the “researcher” to test his theory. It is the welfare of this central, critical element that must be ensured. The culture of individual rights has evolved over the last two centuries. The ancient Greeks, Romans and Egyptians did not practice such a concept. #13 This has brought moral and legal dilemmas that must be discussed and addressed. Respect for persons requires that they be allowed to choose what shall happen to them to the extent that they are capable of understanding. This year, more than 15 million Americans will be recruited into clinical trials. Some will be healthy, alert adults, some will be very ill fragile children-Volunteers will have many faces. Just as the trials will have differing goals, so will the individuals participating in them. The financial stakes are high. Billions of dollars will be invested in this endeavor and there will be both profits and losses. The many interested parties include government regulatory bodies, academic centers, ethicists, commercial interests and the public at large. The immense challenge is to create a system/process that will adequately respond to all. These are challenging times in clinical research. #1 With too much focus on the patient as a subject, there is the chance that there will not be enough focus on the patient as a human being. #1 Key Question-How can the Informed Consent Process be constructed to obtain the maximum value for all concerned? Medical research is the key to the development of new treatments, new drugs, new devices, new procedures and life saving changes in medical care for human beings. Clearly, that medical research can not be conducted without volunteers. It seems that this would be fairly simple given the high regard most people have for the medical community in general and physicians in particular. For thousands of years people have attempted to help and heal their fellows. Often, this took a benign course, but close inspection reveals documented examples of horrible exploitation and research that appears to have been more ‘experimentation’ then true research or care. Formal research, according to Roberta Kalechofsky, PhD. may have found its beginnings in the nineteenth century with the rise of the experimental method in science, and subsequently in medicine. She says,” The history of human experimentation in the West is usefully divided into two eras: before the Nazi era and after. Human experimentation neither arose with the Nazis, nor ended with them.” The best known recent examples are surely the awful experiments that were conducted at Buchenwald, Auschwitz and other camps during the fall of 1939 and through the spring of 1945. Despite the existence of the 1900 Berlin Code, #15 that expressly required that the human subject, in research interventions, must have given his “unambiguous consent” and that there must be proper explanations, researchers proceeded as they wished. Well over two hundred medical doctors were involved; yet later, attempts to expose and punish them ran aground when it became clear that the world governments had no defined principles that covered medical “research” and prosecutors were forced to charge the perpetrators with murder and crimes against humanity (footnote this) instead of accusing them of the horrible crimes committed during their ‘research’. As a result the famous Nuremberg Code, the first international document to provide research ethics guidelines was developed. An interesting side note is that many American and European medical personnel felt that the code was unnecessary and did not apply to them. This had far reaching consequences in the years to come. The Nuremberg Code made voluntary consent and freedom from coercion necessary conditions of clinical research studies. In addition, 1 Lindblad Informed Consent participants must be able to comprehend the risks and benefits of their participation and feel free to leave the project or study if they choose. What Happened: History Anthony S. Kessel says that the word ethics refers to the general beliefs, attitudes or standards that guide customary or community behavior. # 10 Ethics and healthcare have been the subjects of debate and discussion for centuries. However, biomedical ethics - synonymous with medical ethics or healthcare ethics - developed as a discipline of its own in the 1960s, initially in the United State. The emergence of the scientific era, with it’s bursts of curiosity, eruption of information and the explosion of knowledge brought about radical changes in medicine. But the need to know and the urge to explore and discover reasons vastly predate the 1900’s. Cleopatra is said to have wondered about the time it took for a male fetus to develop. She supervised experiments among her maids to test the theory that male fetus was fully developed in 40 days and a female in 80. Her servants were impregnated and killed at differing times of gestation to find the answer. # 7 Wera Sharav records that the Book of Daniel tells of meat and vegetable experiments that were done using Jewish prisoners. Dr. Edward Jenner infected a local child with cowpox and three months later with smallpox in 1776. This lead to widespread policies of vaccination and the eventual eradication of smallpox. However, rarely if ever, is this early researcher criticized for his ‘use’ of the neighborhood child, an expendable person. In1895, the famous chemist E.E. Slosson wrote (and was published in the New York Independent), “A human life is nothing compared with a new fact in science…” #14 In 1913 the Pennsylvania House of Representative recorded 146 children that had been inoculated with the syphilis virus “through the courtesy of various hospitals” and that others had had tuberculin put in their eyes. Several of these children became blind. The experimenters were not punished! #14 In 1931, Dr. Cornelius Rhoads, under the auspices of the Rockefeller Institute for Medical Investigations, infected human subjects with cancer cells. He went on to establish U.S. Army Biological Warfare facilities and was named to the U.S. Atomic Energy Commission. While there, he began a series of radiation exposure experiments on American soldiers and civilian hospital patients. Of great concern, is that frequently, these individuals experienced slight, if any, degree of censure at the time of their research and rarely suffered negative consequences. They often advanced in their careers, earning professional respect and financial stability. This heritage has lead many to continue to advance the defense first suggested by Celus, a physician in the 1st century AD. He is quoted as saying, “It is not cruel to inflict on a few criminals sufferings which may benefit multitudes of innocent people through all centuries.” #20 This certainly supports the use of the ongoing recruitment and use of expendable, vulnerable and disadvantaged individuals in clinical research. Even after the Nuremberg Code was written and accepted, many in the United States continued to experiment under their own individual policies. Perhaps this was encouraged by the fact that although the Japanese had conducted experiments very similar to the Nazi’s (many on American prisoners of war) during the war, the United States government choose to not pursue punishment in exchange according to the Advisory committee on Human radiation Experiments for the information gleaned during those experiments. # 19 # 14, Almost all researchers have now heard of the infamous Tuskegee situation, conducted under the auspices of the United States federal government. Those individuals and their families received a belated apology from President William Clinton in 19______. Even a cursorily look at more recent events shows an ongoing difference in belief systems and personal and institutional practice. More recent examples collected by the Association for Human Research Protection include: 1940’s and 1950’s - The Atomic Energy Commission continued to follow studies that involved giving civilian’s cereal that had radioactive tracers. 1947 - The CIA began its study of LSD as a potential weapon for use by American intelligence. Human subjects (both civilian and military) were used with and without their knowledge. 2 Lindblad Informed Consent 1950 – The Department of Defense began plans to detonate nuclear weapons in desert areas and monitor downwind residents for medical problems and mortality rates. 1950 - In an experiment to determine how susceptible an American city would be to biological attack, the U.S. Navy sprayed a cloud of bacteria from ships over San Francisco. Monitoring devices were situated throughout the city in order to test the extent of infection. Many residents become ill with pneumonia-like symptoms. 1956 – The U.S. military releases mosquitoes infected with Yellow Fever over Savannah, Georgia and Avon Park, Florida. Following each test, Army agents posing as public health officials tested victims for effects.